(52 days)
The Veloxion System is intended for use by trained urologists for endoscopically controlled tissue chip resection and coagulation, and removal of prostate adenomas via suction channel under continuous flow conditions following resection using a bipolar resecting device.
The Veloxion System consists of the following components: Veloxion Controller (with Integrated Fluid Control) with Footswitch, Veloxion Resectoscope, Veloxion Fluid Control Set, Veloxion Video Control Unit, and Veloxion Roll Stand. The system also includes Class I accessories for handling waste: Waste Management Tubing and Tissue Catch. The system provides bipolar resection and coagulation of prostate adenomas, distends the cavity by filling with saline, and provides pressure control of the cavity to facilitate viewing with the integrated Resectoscope.
This 510(k) summary for the Veloxion System (K190099) does not include a detailed study with acceptance criteria and reported device performance in the format of a table, nor does it provide a multi-reader multi-case comparative effectiveness study or details on standalone algorithm performance.
However, based on the provided text, here's an attempt to outline the acceptance criteria and study information where available, focusing on what can be inferred or directly stated.
Acceptance Criteria and Reported Device Performance
The document does not provide a formal table of acceptance criteria with specific numerical targets and corresponding reported device performance. Instead, it lists various non-clinical tests performed to demonstrate safety and effectiveness and substantial equivalence to a predicate device. The general acceptance criterion implied across all these tests is that the subject device performs as safely and effectively as the predicate device, or meets relevant industry standards.
Here's a summary of the performance claims based on the non-clinical testing data:
| Acceptance Criterion (Implied) | Reported Device Performance (Summary from text) |
|---|---|
| System Integrity (withstanding operating pressures) | "System withstands operating pressures" |
| Functional Performance (Cut, Coagulation, Aspiration, Irrigation, Pressure Control) | "Cut and coagulation, aspiration, irrigation, pressure control" functions are met. Specific programmed flow rates are detailed (e.g., Steady State = 50ml/min, Cut = 380ml/min, Coag = 50ml/min, ASPIRATE = 400ml/min), and the device is able to set cavity pressure (20 to 60mmHg) and monitor saline. Over-pressure detection and mitigation (maximum 75mmHg, non-defeatable notification) are present. |
| Dimensional Accuracy | "Dimensional Inspection and Testing" performed, with Max. Shaft OD (Sheath) of 25Fr (8.3mm) and Working Length of 220mm, which are comparable to the predicate (26Fr, 193mm). |
| Thermal Performance (LED Tip Temperature) | "Maximum LED Tip Temperature" testing performed. |
| Visualization Performance | "Comparative visualization testing in a simulated model" performed. The device includes an "Integrated, Sterile, 10degree Endoscope," differing from the predicate's reusable 30° endoscope, but presumably demonstrating equivalent visualization quality. |
| Simulated Use Performance (Tissue resection, spot coagulation, cavity pressure, imaging) | "Simulated Use: Tissue resection and spot coagulation of cavity pressure, imaging" performed. |
| Durability (Electrode) | "Durability Testing: Electrode durability testing for tissue resection and coagulation." "Comparative testing to predicate for electrode durability." (Conclusion implies equivalence). |
| Biocompatibility | "Biocompatibility Testing: In accordance with ISO 10993-1" (Indicates compliance with the standard). |
| Sterility | "Sterility: In accordance with ISO 11135:2014, ISO 11137-1:2006, ISO 11137-2:2013" (Indicates compliance with the standards, device supplied sterile, single use). |
| Packaging Integrity | "Packaging: In accordance with ASTM D4169:14 and ISO 11607-1:2006" (Indicates compliance with the standards). |
| Shelf-life | "Shelf-life: In accordance with ASTM F1980:2007" (Indicates compliance with the standard). |
| Electrical Safety & EMC | "Electrical Safety & EMC: In accordance with IEC 60601-1:2005, IEC 60601-1-2:2014, IEC 60601-2-18:2009 and IEC 60601-2-2:2009" (Indicates compliance with the standards). |
| Usability | "Usability Testing: Use related risk evaluation" performed. |
| Software Performance | "Software Verification and Validation Testing performed per IEC 62304 and documentation provided per FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."" (Indicates compliance with software standards and guidance). |
Here's the additional information requested, based on the provided text:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not specify sample sizes for any of the non-clinical tests.
- The data provenance (country of origin, retrospective/prospective) is not provided. All tests listed are non-clinical, implying laboratory or simulated environments, rather than patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This information is not provided. No clinical studies are described, therefore "ground truth" in the clinical sense (e.g., from expert diagnoses) is not applicable here. The "ground truth" for the non-clinical tests would be the established engineering and medical standards and functional specifications that the device is tested against.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not provided and is not applicable to the non-clinical testing described. Adjudication methods are typically associated with clinical studies involving human observers or diagnoses.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned. This device is an active medical device (resectoscope system) for prostate adenoma resection, not an AI-powered diagnostic or assistive tool for image interpretation by human radiologists/clinicians in the sense that MRMC studies typically evaluate. The "visualization testing in a simulated model" is the closest mentioned, but it's not an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This device is not an algorithm or AI system in the typical standalone sense. It's a surgical system with integrated software and controls. While software verification and validation were performed (per IEC 62304), this refers to the performance of the integrated software controlling the device's functions, not a standalone AI algorithm producing diagnostic or predictive outputs.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical tests, the "ground truth" would be objective measurements against established technical specifications, engineering principles, and relevant international and national standards (e.g., ISO, IEC, ASTM standards mentioned in the text). For fluid flow, pressure control, temperature, electrical safety, durability, and biocompatibility, the ground truth is the scientific and engineering benchmarks and standards themselves. For "simulated use" and "comparative visualization," the "ground truth" would involve demonstrating the device's ability to achieve its intended function effectively within the simulated environment, comparable to the predicate.
8. The sample size for the training set
- This information is not applicable. The Veloxion System is a physical medical device with integrated software for control, not a machine learning or AI model that requires a "training set" to learn from data.
9. How the ground truth for the training set was established
- This information is not applicable for the reasons stated in point 8.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.